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EC number: 281-589-3
CAS number: 83969-12-4
The influence of Basic Blue 159 upon organogenesis and the
subsequent outcome of pregnancy was assessed in sexually mature female
rats of the CD strain. For the purpose of this preliminary assessment,
Basic Blue 159 was administered by gavage at dose levels of 5, 20, or 80
mg/kg body weight/day to groups of 6 pregnant female rats from Day 6 to
Day 15 inclusive of gestation. Control animals received the vehicle,
distilled water, throughout the same period. All females were killed on
Day 20 of gestation for examination of their uterine contents.
Females receiving 5 mg/kg body weight/day showed no adverse
response to treatment. At 20 and 80 mg/kg body weight/day all females
exhibited excessive salivation after dosing. Five females receiving 80
mg/kg body weight/day were terminated before the end of treatment
because of marked adverse responses, which included prone posture,
lethargy, tremor, irregular respiration and loss of the eye closure
reflex. At necropsy three of these females were found to have ulcerated
areas in the fundic region of the stomach.
Weight gain of females receiving 5 mg/kg body weight/day was
comparable with that of the control group. Females receiving
20 mg/kg body weight/day showed an initial, transient, reduction
of weight gain, the subsequent rate of gain was comparable with that of
the Controls. Weight gain of the single female that survived at 80 mg/kg
body weight/day was depressed during the majority of the treatment
period, but subsequeritly improved to the control rate of gain post
Food intake of females receiving 5 mg/kg body weight/day was
unaffected by treatment. Females receiving 20 mg/kg body weight/day
showed a marginal depression during the last four days of treatment, but
subsequently recovered to control values. At 80 mg/kg body weight/day,
food intake of the one surviving animal was reduced from the start of
the treatment period.
Water intake of females receiving 5 and 20 mg/kg body weight/day
was unaffected by treatment. At 80 mg/kg body weight/day, water intake
was depressed during Days 9 to 15 of gestation, but subsequently
improved to control values.
Litter responses of females receiving 5 and 20 mg/kg body
weight/day were unaffected by treatment. Mean foetal and placental
weight was reduced and pre-implantation loss was increased in the single
surviving litter at 80 mg/kg body weight/day.
It was concluded from this preliminary investigation that there
were no indications to a teratogenic effect of Basic Blue 159. For the
main study the highest dose should not exceed 20 mg/kg body weight/day.
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